An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intramuscularly Administered Rabies Immune Globulin (Human)

Exclusion Criteria

• •Pregnant or lactating females.
• •Clinical evidence of any significant acute or chronic disease that may interfere with successful completion of the trial.
• •Clinically significant history of the following: cardiovascular disease, hyperlipidemia, serious respiratory disease including bronchitis or asthma, endocrine disorder, liver disease, glaucoma, gastrointestinal disease, disorder of the reticuloendothelial system, or neurologic illness.
• •History of angioedema or nephrotic syndrome.
• •Non-controlled arterial hypertension.
• •Anemia at screening.
• •Significant proteinuria (\> 1 + on urine dipstick) and/or has a history of acute renal failure and/or severe renal impairment or a blood urea nitrogen or creatinine more than 2.5 times the upper limit of normal at screening and/or currently receiving dialysis.
• •Elevated liver enzymes (aspartate transaminase, alanine aminotransferase) and Gamma-glutamyl Transferase) equal to or greater than 1.5 times the upper limit at screening.
• •Previously received the rabies vaccine and/or rabies immune globulin.
• •Received infusion of a blood/plasma product or fraction within the past 12 months, including any type of immune globulin.
• •Known adverse reaction to administration of any immune globulin or other blood/plasma products.
• •Experienced anaphylactic shock with the administration of blood/plasma products.
• •Known medical history of selective immunoglobulin A (IgA) deficiency.
• •Received any corticosteroids, immunosuppressants, or immunomodulators within 6 weeks prior to screening.
• •Expects to receive oral or topical non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, antihypertensives, and/or antihistamines 24 hours before or after investigational product administration during the Baseline/Treatment, Study Day 0 visit.
• •Currently receiving any anti-viral treatment.
• •Screening laboratory results indicative of an acute or chronic infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or parvovirus B19 (B19V).
• •Participated in another clinical trial within 30 days prior to screening (imaging studies without investigative treatments are permitted) or has received any investigational products within the previous 3 months.
• •Not willing to postpone receiving any live virus vaccines until 3 months after receiving investigational product.
• •History of a psychiatric illness requiring hospitalization.
• •Known substance or prescription drug abuse in the past 12 months.
• •Any active medical illness that the Investigator may consider a potential confounding condition that would interfere with the study visits and/or procedures.